CLINITEK Novus® Automated Urine Chemistry Analyzer 10697937Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu · Class 1
All models of CLINITEK Novus Automated Urine Chemistry Analyzer (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00630414981147), received between Mar 28, 2018 and Nov 20, 2024 — classified as 20 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (17 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result17
- Low Test Results1
- Non Reproducible Results1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738173 ↗MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738017 ↗MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED A FALSE NEGATIVE RED BLOOD CELL (RBC) RESULT ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737692 ↗MalfunctionNov 15, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20698427 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584871 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584867 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584850 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED A FALSE NEGATIVE RED BLOOD CELL (RBC) RESULT ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584834 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519064 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518918 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT THREE PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514435 ↗MalfunctionOct 10, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED TWO FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING TWO DIFFERENT LOTS OF THE NOVUS CASSETTES. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416155 ↗MalfunctionJul 23, 2024Low Test Results; Low Test Results
THE CUSTOMER ALLEGED AN ISSUE WITH THE CLINITEK NOVUS VERSES THE ATELLICA UAS 800 AFTER INSTALLATION WHERE THE NOVUS WAS GIVING LESS LEUKOCYTES (LEU) THAN WHITE BLOOD CELLS (WBC). THE CASSETTE WAS CALIBRATED AGAIN BUT KEEPS GIVING LESS LEU THAN IT SHOULD. THE MICROSCOPIC PICTURES SHOW THAT THE ATELLICA UAS 800 IS MEASURING THE PARTICLE WELL, BUT IT DOES NOT IN ANY WAY MEET THE MEASUREMENTS IN THE NOVUS. THE ESCALATION WAS OPENED AGAINST THE CLINITEK NOVUS, BUT THE CUSTOMER DOES NOT KNOW WHICH ANALYZER'S RESULTS ARE EXPECTED TO BE TRUE. THERE WAS NO REPORT OF HARM DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19809967 ↗MalfunctionDec 2, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEIR CLINITEK NOVUS INSTRUMENT GAVE A FALSE NEGATIVE LEUKOCYTE RESULT COMPARED TO RETESTING THE SAME PAITENT SAMPLE USING A VISUAL READ MULTISTIX 10SG URINE STRIP . THE CUSTOMER ALSO REPORTED THE APPERANCE OF THIS PAITENT SAMPLE WAS NOTABLY CLOUDY. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15901292 ↗MalfunctionDec 1, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEIR CLINITEK NOVUS INSTRUMENT GAVE A FALSE NEGATIVE LEUKOCYTE RESULT COMPARED TO RETESTING THE SAME PATIENT SAMPLE USING A VISUAL READ MULTISTIX 10SG URINE STRIP. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15899522 ↗MalfunctionSep 2, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEIR CLINITEK NOVUS INSTRUMENT GAVE A FALSE NEGATIVE LEUKOCYTE RESULT COMPRED TO RETESTING OF THE SAME SAMPLE ON A SEDIMENT ANALYZER AND ANOTHER CHEMISTRY ANALYZER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15352403 ↗MalfunctionOct 2, 2020Smoking; Smoking
THE CUSTOMER PLUGGED THE PRINTER INTO A NEW SAFETY OUTLET AND THE PRINTER STARTED SMOKING, NO SPARKS OR FLAMES. CUSTOMER UNPLUGGED THE PRINTER. THE CUSTOMER INSPECTED THE PRINTER AND SAID A TONER CARTRIDGE BURST INSIDE THE PRINTER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10619132 ↗MalfunctionMay 14, 2019Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED FALSELY DEPRESSED LEUKOCYTES ON THE CLINITEK NOVUS WHEN COMPARED TO THE MICROSCOPIC EXAMINATION OF THE URINE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609857 ↗MalfunctionJan 9, 2019False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE LEUKOCYTE RESULTS ON THE NOVUS WHEN COMPARED TO THE MICROSCOPIC SEDIMENT READING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232105 ↗MalfunctionMar 28, 2018False Negative Result; False Negative Result
THE CUSTOMER REPORTED DISCREPANT BLOOD RESULTS IN URINE BETWEEN THE CLINITEK NOVUS AND A MICROSCOPIC EXAMINATION OF THE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7376928 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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